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Transportation and Cold Chain Workshop

December 17, 2020 @ 8:00 am - 5:00 pm

Transportation and Cold Chain Workshop

Register online

Dates Available

February 26, 2021

Time

11:00 a.m. – 2:00 p.m.

Cost

CAD $485.00 + HST

Location

Online

Distinguished Faculty

Mr. Tonino Antonetti

Live interactive and instructor led

Mr. Tonino Antonetti has over 25 years of experience in the Pharmaceutical and Medical Device industries. He has acquired extensive experience and understanding of Clinical Operations Packaging and Labelling, Sterile manufacturing, Validation Management, Quality Assurance, Regulatory Licensing and Compliance. He also worked with the Canadian Regulatory body, Health Canada. While at Health Canada, he worked in the Drug Investigation Unit, the Medical Device Unit and the GMP Inspection Unit where he was a member of the GMP Committee and contributed to the development and enhancement of Regulations, Policies and Guidelines, including Health Canada Guide-00069 on Temperature control. He also is an active member and responsible of the IVDD sub-committee for the Canadian Medtech Association that represents and supports the Canadian Medical Device industry.

Mr. Antonetti is currently holds the position of Executive Director, Regulatory Affairs & Quality Management – Safety, Health and Environment at the Canadian affiliate at Roche Diagnostics where he is responsible for all aspects of Licensing, Compliance, Quality and Safety. He also takes part of many of Roche Global projects and has the opportunity to lead teams through different Quality and Regulatory Agile and Transformation projects. He holds a Bachelor of Science (B.Sc.) degree in Medical Biology from the University de Quebec à Trois-Rivières and a Master’s of Science degree (M.Sc.) in Biophysics with a Specialization in Neuropharmacology from the same institution.

His peers recognize him as being an individual with high energy, passion and with great leadership skills. Tonino takes genuine interest in mentoring local colleagues and across Roche’s network as he seeks to discover and develop the potential in people to guide them to reach their fullest potential. He constantly goes all-out to achieve excellence and extraordinary results. Tonino is a person that strives every day to lead by example, consistently demonstration his values of Integrity, Courage and Passion, takes the time to listen, and encourages colleagues to pursue their goals.

Overview

The crucial steps to maintain Drug and Medical Devices integrity: The final miles play a crucial role on the product temperature.

This workshop will provide an overview of controls to take in consideration during the transportation of drugs and medical devices. An effective and efficient environmental temperature control process for drugs and medical devices during storage and transportation is critical to guarantee product integrity. It is vital to preserve drug and medical device safety, quality and efficacy. One important factor that can affect the product integrity occurs mainly during the supply chain process. This usually occurs during the final miles of delivery of products to the final distribution point. Usually the person that dispenses or provides drugs/tests to the patient. We will look at different controls or opportunities available to prevent the products from being non-compliance with their temperature requirements. The workshop will look at real case situations, such as the Vaccination for Covid-19 and the logistics required behind this.

Course Outline

The general overview of the workshop details will include:

  • Basics of environmental controls of drugs and medical device storage and transportation
  • The role of environmental controls
  • Warehousing and storage
  • Considerations for shipping and receiving areas
  • Examples Packaging configurations
  • Sample products available on the market
  • Traceability
  • Documentation
  • What are the new ways to manage cold chain distribution (i.e. Covid-19 Vaccines)
  • Real Life examples
  • Questions and answer period

Note: Course outline may be subject to subject to change without notice. Additional topics may be added.

Who should attend:

Departments to which the workshop would apply to but not limited to:

  • Pharmaceutical professionals in following disciplines: Operations, Production, Quality Operation, Logistics/supply chain, Regulatory Affair
  • Regulatory Agencies professionals
  • Packaging manufacturing professionals with R & D role
  • Pharmaceutical distributors
  • Supply chain management professionals
  • Logistics service providers – trucking, airlines, couriers, freight forwarder, warehouse, cold storage…etc.
  • Consultants

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Details

Date:
December 17, 2020
Time:
8:00 am - 5:00 pm

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